Melanoma Clinical Trial

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

Summary

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).

Exclusion Criteria:

Participants must not have ocular melanoma.
Participants must not have a history of myocarditis, regardless of etiology.
Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

814

Study ID:

NCT05625399

Recruitment Status:

Not yet recruiting

Sponsor:

Bristol-Myers Squibb

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There are 46 Locations for this study

See Locations Near You

Dignity Health - St. Josephs Hospital and Medical Center
Phoenix Arizona, 85013, United States More Info
Miguel Gonzalez Velez, Site 0125
Contact
Stanford Univ Med School Dept of Dermatology
Stanford California, 94305, United States More Info
Sunil Reddy, Site 0123
Contact
650-743-4516
Ft. Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46804, United States
Greenebaum Cancer Center University of Maryland
Baltimore Maryland, 21201, United States More Info
Petr Hausner, Site 0146
Contact
410-328-6896
Rutgers CINJ
New Brunswick New Jersey, 08901, United States
St. Lukes University Health Network
Easton Pennsylvania, 18045, United States More Info
Melissa Wilson, Site 0139
Contact
212-731-6160
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States More Info
Rino Seedor, Site 0124
Contact
215-847-7409
Intermountain Medical Center Campus Location
Murray Utah, 84107, United States More Info
David Gill, Site 0122
Contact
Local Institution - 0042
Caba Buenos Aires, 1125, Argentina
Local Institution - 0133
Ciudad Autonoma de Buenos Aires Buenos Aires, 1426, Argentina More Info
Site 0133
Contact
Local Institution - 0145
Caba Ciudad Autonoma De Buenos Aires, 1430, Argentina More Info
Site 0145
Contact
Local Institution - 0118
Wagga Wagga New South Wales, 2650, Australia More Info
Site 0118
Contact
Local Institution - 0033
Westmead New South Wales, 2145, Australia More Info
Site 0033
Contact
Local Institution - 0030
Prahran Victoria, 3004, Australia More Info
Site 0030
Contact
Local Institution - 0027
Graz , 8036, Austria More Info
Site 0027
Contact
Local Institution - 0078
Charleroi Hainaut, 6000, Belgium More Info
Site 0078
Contact
Local Institution - 0025
Ijui Rio Grande Do Sul, 98700, Brazil More Info
Site 0025
Contact
Local Institution - 0132
Florianopolis Santa Catarina, 88034, Brazil More Info
Site 0132
Contact
Local Institution - 0018
Sao Jose do Rio Preto Sao Paulo, 15090, Brazil More Info
Site 0018
Contact
Local Institution - 0130
Sao Paulo , 01321, Brazil More Info
Site 0130
Contact
Local Institution - 0141
Calgary Alberta, T2N 4, Canada More Info
Site 0141
Contact
Local Institution - 0121
Hamilton Ontario, L8V 5, Canada More Info
Site 0121
Contact
Local Institution - 0143
Temuco Araucania, 48008, Chile More Info
Site 0143
Contact
Local Institution - 0140
Recoleta Metropolitana, 83804, Chile More Info
Site 0140
Contact
Local Institution - 0144
Santiago Metropolitana, 01010, Chile More Info
Site 0144
Contact
Local Institution - 0142
Vitacura Metropolitana, JC5G , Chile More Info
Site 0142
Contact
Local Institution - 0119
Santiago de Chile Providencia, 75006, Chile More Info
Site 0119
Contact
Local Institution - 0108
Toulouse Haute Garonne, 31059, France More Info
Site 0108
Contact
Local Institution - 0128
Bayonne , 64100, France More Info
Site 0128
Contact
Local Institution - 0127
Chambray-les-Tours , 37044, France More Info
Site 0127
Contact
Local Institution - 0129
Clermont Ferrand , 63003, France More Info
Site 0129
Contact
Local Institution - 0046
Dijon , 21000, France More Info
Site 0046
Contact
Local Institution - 0052
Pierre-Benite , 69310, France More Info
Site 0052
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Local Institution - 0061
Villejuif Cedex , 94805, France More Info
Site 0061
Contact
Local Institution - 0137
Ludwigshafen A. Rhein Rheinland-Pfalz, 67063, Germany More Info
Site 0137
Contact
Local Institution - 0136
Dortmund , 44137, Germany More Info
Site 0136
Contact
Local Institution - 0135
Goettingen , 37075, Germany More Info
Site 0135
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Local Institution - 0138
Hamburg , 20251, Germany More Info
Site 0138
Contact
Local Institution - 0051
Bari , 70124, Italy More Info
Site 0051
Contact
Local Institution - 0104
Monterrey Nuevo Leon, 64460, Mexico More Info
Site 0104
Contact
Local Institution - 0131
Puebla , 72424, Mexico More Info
Site 0131
Contact
Local Institution - 0021
Krakow , 30-51, Poland More Info
Site 0021
Contact
Local Institution - 0134
Badalona , 08916, Spain More Info
Site 0134
Contact
Local Institution - 0126
Madrid , 28009, Spain More Info
Site 0126
Contact
Local Institution - 0069
Uppsala , 751 8, Sweden
Local Institution - 0120
Newcastle upon Tyne Northumberland, NE7 7, United Kingdom More Info
Site 0120
Contact

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

814

Study ID:

NCT05625399

Recruitment Status:

Not yet recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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